This program will commercialize a high-speed, high-resolution, neuroendovascular imaging platform that allows neurointerventionalists to directly visualize intravascular devices and their interaction with vessels during treatment of brain aneurysms. The miniaturization of the design features of neurovascular stents and flow-diverters has enabled an explosion of technologies available for endovascular treatment of stroke. However, imaging technology has not kept pace with device technology to enable endovascular surgeons sufficient resolution to adequately visualize the device-vessel relationship. As such, there is a critical need for high-resolution imaging specific to cerebrovascular disease and endovascular treatments. Optical coherence tomography (OCT) is a relatively new imaging technique approved by FDA for intracoronary imaging that delivers the highest axial resolution (?12 m) among all the other available modalities. However, commercially available OCT solutions are not compatible with microcatheters used for neuro-endovascular intervention and are unsuitable for highly tortuous neurovascular anatomy. During SBIR Phase I, Gentuity demonstrated a reduced size, high-resolution, high-frequency OCT imaging probe designed for cerebrovascular imaging (the Vis-N device). The Vis-N is compatible with neurovascular microcatheter delivery tools and workflow and can navigate tortuous vasculature using novel optics and scanning mechanisms. We successfully demonstrated the feasibility of the proposed technology in a combination of in vitro vascular phantoms and in vivo pre-clinical models, including cutting edge neuroendovascular implants.
The aim of the submitted project is to further develop the proposed imaging device for clinical use and to demonstrate its safety and efficacy in a pre-clinical model. Upon completion of this Phase 2 application, we will be poised to study this neurovascular imaging catheter in an IDE to obtain regulatory approval and enter the commercialization phase. !

Public Health Relevance

The goal of this program is to provide a highly effective, high-resolution, imaging tool for the guidance of endovascular procedures for brain aneurysm repair. X-ray angiography, computed tomography (CT) and magnetic resonance imaging (MRI) are the primary imaging modalities used in the clinic to provide perioperative guidance for aneurysm repair procedures, however, they lack sufficient resolution to adequately assess device-vessel interaction. In this application, we propose to advance to commercialization a reduced-size, high-speed, high-resolution, optical imaging probe optimized for cerebrovascular imaging such that it is compatible with neurovascular microcatheter delivery tools and is capable of imaging while navigating the tortuous vascular anatomy.

National Institute of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1)
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Fertig, Stephanie
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Gentuity, LLC
United States
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